Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized tucatinib in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have at least 2 prior anti-HER2 treatment regimens.

This is written in the approval document as:

TUKYSA is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least 2 prior anti-HER2 treatment regimens.

Citation

Seagen B.V. Tukysa (tucatinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/tukysa-epar-product-information_en.pdf. Revised August 2023. Accessed March 25, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	HER2-positive	Invasive Breast Carcinoma	Capecitabine, Trastuzumab, Tucatinib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2021-02-11	European Medicines Agency	Indication received approval from the European Commission.